1. Technical Field
The present disclosure relates to oral devices for reducing or eliminating obstructive sleep apnea, snoring and/or nasal drainage.
2. Background Art
Sleep apnea is a reduction in the blood oxygen level due to any cause. The present disclosure relates to “obstructive sleep apnea”, which is problematic for many people—about 12 to 18 million people in the United States as of 2008. Obstructive sleep apnea (OSA) involves a reduction in breathing, called hypopneas, or a complete halt in airflow, called apneas, during sleep. Most pauses last 10 to 30 seconds, but some may persist for one minute or longer, according to the American Academy of Sleep Medicine. See Landers, S J, “Link strengthened between sleep apnea and mortality risk”, amednews, Sep. 1, 2008. As indicated in this article, apnea has been linked to higher mortality risks.
There are of course many known devices which claim to reduce or eliminate OSA, and these devices typically fall in two categories: external masks, such as the CPAP (continuous positive airway pressure) masks; and oral devices, sometimes referred to as mandibular splints. Pharmaceuticals comprise another category. The present disclosure involves the oral device or mandibular splint category.
Another discomfort is nasal or sinus drainage, sometimes referred to as nasal or sinus congestion, nasal or sinus drip, nasal or sinus irritation. The term “nasal drainage” is used herein to include all of these conditions unless otherwise noted. Non-oral products, such as adhesive strips positioned on the nose, may relieve some of these symptoms. However, nasal strips may only reduce anterior (frontal) congestion, and not posterior (throat) congestion.
Many of the known oral devices are uncomfortable and/or complicated, leading to reduced use. Furthermore, their use in humans may reduce speaking substantially, or at least the ability to speak understandably. In my co-pending application Ser. No. 13/456,682, filed Apr. 26, 2012, now issued as U.S. Pat. No. 9,144,512, incorporated herein by reference, certain embodiments include left and right ramps designed to move the lower mandible (lower jaw) downward as it moves backward toward a users throat. While I have found devices of this nature to be effective in reducing or eliminating my sleep apnea and snoring, and met a long felt and unmet need for an oral device, apparatus or kit, and methods of using these, to efficiently, safely and comfortably reduce or prevent OSA, snoring, and/or nasal drainage, the shape of the ramps may be complicated to manufacture. In particular, the ramps disclosed in my previous patent application each have complicated mating surfaces. Considering FIG. 8 of my '512 patent, specifically the right ramp, the right ramp may be described as being defined by three upper right surfaces or faces, with smooth transitions from face to face, and three mating lower right surfaces or faces, that interface and that must move smoothly against each other at any given time: a flat front, generally horizontal face, a generally slanted face, and a generally flat rear, generally horizontal face. The same may be said of the left ramp. Therefore, each side has three interfaces, for a total of six interfaces for the device, which must move smoothly to be comfortable and effective for users.
Another device, disclosed in WO20100093264A1, is designed for use in medical procedures to repair damaged facial features. The devices include left and right forward inclined ramps on the lower tray of the device. Ramps of suitable height could alternately be positioned on the upper tray only, or on both trays. However, this device also includes engagement features to engage posterior portions of upper and lower trays to stabilize the upper and lower trays relative to one another, and thereby stabilize the subject's upper and lower jaw relative to one another, in contrast to the goal of the present devices. Such stabilization in devices designed to prevent snoring and/or sleep apnea are highly undesirable, as they lead to jaw soreness and stiffness, and ultimately lead to non-use.
I have now designed an oral device that reduces possible alignment problems with my previous device and devices of like nature, and which is easier to manufacture.